Hazardous contaminant collection device with integrated swab and test device

ABSTRACT

Contamination detection systems, kits, and techniques are described for testing surfaces for the presence of analytes of interest, including hazardous contaminants, while minimizing user exposure to these contaminants. Even trace amounts of contaminants can be detected. A collection device provides a swab that is simple to use, easy to hold and grip, allows the user to swab large areas of a surface, and keeps the user&#39;s hands away from the surface being tested. The collection device also includes a test strip, and provides a closed fluid transfer mechanism to transfer the collected fluid from the swab to the test strip while minimizing user exposure to hazardous contaminants in the collected fluid. Contamination detection kits can rapidly collect and detect hazardous drugs, including trace amounts of antineoplastic agents, in healthcare settings at the site of contamination.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/797,804, filed Jan. 28, 2019, which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The systems and methods disclosed herein are directed to environmentalcontaminant testing, and, more particularly, to a test kit for detectingthe presence and/or quantity of antineoplastic agents.

BACKGROUND

Antineoplastic drugs are used to treat cancer, and are most often foundin a small molecule (like fluoruracil) or antibody format (likeRituximab). Detection of antineoplastic drugs is critical fordetermining if there is contamination/leakage in hospital/pharmacy areaswhere the drugs are used and/or dispensed.

The nature of antineoplastic agents make them harmful to healthy cellsand tissues as well as the cancerous cells. Precautions should be takento eliminate or reduce occupational exposure to antineoplastic agentsfor healthcare workers. Pharmacists who prepare these drugs and nurseswho may prepare and administer them are the two occupational groups whohave the highest potential exposure to antineoplastic agents.Additionally, physicians and operating room personnel may also beexposed through the treatment of patients. Hospital staff, such asshipping and receiving personnel, custodial workers, laundry workers andwaste handlers, all have the potential to be exposed to these drugsduring the course of their work. The increased use of antineoplasticagents in veterinary oncology also puts these workers at risk forexposure to these drugs.

SUMMARY

Existing approaches to detecting a hazardous drug contamination requirethe user to manually handle sample swabs directly by hand, press theswab material by hand when wiping a test surface, place the sampledswabs into a test tube/vial, and send the sample-impregnated swab to anoutside laboratory for testing. Directly handling a swab embedded withhazardous contamination is potentially dangerous for the test user.Further, these existing approaches use a small cotton swabs on a stickwhich covers very little surface area, requiring significant work andtime from the user. Further, the results can come back weeks (sometimesup to nine weeks) after when the test was taken, delaying anydecontamination response.

These and other problems are addressed in embodiments of the collectionand testing kit described herein that avoids further spread and exposureof contamination during the process of collecting the sample and quicklyprovides accurate test results at the site and time of testing. Thepresent technology provides a collection device and detection system fortesting of various surfaces in healthcare settings for the presence ofantineoplastic agents while minimizing user exposure to these agents.The collection device is capable of detecting even trace amounts ofantineoplastic agents and of providing results quickly (includingimmediately after collection). Advantageously, testing and detectionoccur at the location of the collection. The collection device providesa swab that is simple to use, easy to hold and grip, allows for swabbingof large surfaces, and keeps the user's hands away from the surface andfluid being tested. Beneficially, the swab is integrated with the testassay in a fluid-tight manner, providing for leak-free transfer of thecollected fluid from the swab to the assay. As such, the collectiondevice includes the swab, optionally a fluid reservoir, and an assay (orother detection system) integrated into a single, fluid-tight device.

One suitable detection system includes an immunoassay device.Immunoassay devices play an important role in areas such as clinicalchemistry and have been made portable for use in the field. Immunoassaytechnology provides simple and relatively quick means for determiningthe presence of analytes in a subject sample. Analytes are substances ofinterest or clinical significance that may be present in biological ornon-biological fluids. The analytes can include antibodies, antigens,drugs, or hormones. The analyte of interest is generally detected byreaction with a capture agent, which yields a device more easilydetected and measured than the original analyte. Detection methods caninclude a change in absorbance, a change in color, change influorescence, change in luminescence, change in electrical potential ata surface, change in other optical properties, or any other easilymeasured physical property indicating the presence or absence of ananalyte in a sample.

Accordingly, one aspect relates to a hazardous contamination detectionsystem including a collection device. The collection device includes anelongate body forming an enclosure. The collection device also includesan assay test strip disposed within the enclosure. The assay test stripincludes a reaction zone configured to produce an optically-detectablechange in appearance in the presence of a hazardous contaminant. Thecollection device also includes an absorbent swab material coupled tothe elongate body. The swab material is moistened with a solutionconfigured to lift the hazardous contaminant from a test surface. Theelongate body forms a handle having a first end coupled to the absorbentswab material, a second end spaced apart from the first end, and anelongate length extending therebetween. The collection device furtherincludes a fluid-tight enclosure including a fluid pathway between theabsorbent swab material and the test strip.

Another aspect relates to a hazardous contaminant collection device. Thehazardous contaminant collection device includes an elongate bodyforming an enclosure. The hazardous contaminant collection device alsoincludes an assay test strip disposed within the enclosure. The assaytest strip includes a reaction zone configured to produce anoptically-detectable change in appearance in the presence of a hazardouscontaminant. The hazardous contaminant collection device also includesan absorbent swab material coupled to the elongate body. The swabmaterial is moistened with a solution configured to lift the hazardouscontaminant from a test surface. The elongate body forms a handle havinga first end coupled to the absorbent swab material, a second end spacedapart from the first end, and an elongate length extending therebetween.The hazardous contaminant collection device also includes a fluid-tightenclosure including a fluid pathway between the absorbent swab materialand the test strip.

Still another aspect relates to a method of testing a test surface forthe presence of a hazardous contaminant. The method includes removing acap from an elongate body of a collection device to expose an absorbentswab material coupled to an end of the elongate body. The absorbent swabmaterial is pre-moistened with a first volume of a solution configuredto lift the hazardous contaminant from the test surface. The method alsoincludes wiping the test surface with the absorbent swab material tocollect the hazardous contaminant from the test surface. The methodfurther includes reapplying the cap to the elongate body to seal theabsorbent swab material to isolate the collected hazardous contaminantwithin the collection device. The method also includes transferring avolume of liquid from the absorbent swab material to an assay test stripvia a fluid-tight path within the collection device, wherein the assaytest strip is sealed within the collection device. The method furtherincludes inserting the assay test strip into an assay reader device. Themethod also includes identifying that the hazardous contaminant ispresent on the test surface based on an output of the assay readerdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIG. 1 illustrates example steps of a testing method using a contaminantcollection device as described herein.

FIGS. 2A-2C show example steps of using a collection device with anintegrated swab and test strip during various portions of the testingmethod of FIG. 1.

FIGS. 3A and 3B illustrate an example testing device that can be usedwith the testing method of FIG. 1.

FIGS. 4A-4D depict an embodiment of a collection device with anintegrated swab material and assay device.

FIGS. 5A-5G depict another embodiment of a collection device with anintegrated swab material and test device.

FIGS. 6A-6E depict another embodiment of a collection device with anintegrated swab material and test device.

FIG. 7 depicts a high level schematic block diagram of an example readerdevice that can read the test devices of FIGS. 4A-6E.

FIG. 8 depicts a high level schematic block diagram of an examplenetworked test system environment that can include the reader device ofFIG. 7.

FIG. 9 depicts a flow chart of an example process for test datageneration, analysis, and reporting using the collection devices andreader devices described herein.

DETAILED DESCRIPTION

Introduction

Embodiments of the disclosure relate to systems and techniques fordetection of hazardous environmental contaminants, such as but notlimited to antineoplastic drugs used in the treatment of cancer, whileminimizing exposure of the test operator to the contaminants. A kit forsuch testing can include a collection device and a testing device.Throughout this disclosure, example systems, kits, and methods will bedescribed with reference to collection, testing, and detection ofantineoplastic agents, but it will be understood that the presenttechnology can be used to collect, test, and detect any particle,molecule, or analyte of interest.

A collection device can include an integrated swab and testing apparatussuch as a lateral flow assay test strip. Beneficially, the collectiondevice provides a fluid-tight fluid path between the swab and the teststrip, such that the user is protected from collected liquid as it istransferred from the swab to the test strip. The collection device canalso include a cap or other container for sealing the swab aftercollection of the antineoplastic agent. Optionally, a reservoir forcontaining fluid such as a buffer solution can be disposed in the capfor flushing the swab after sample collection. The swab can beconstructed from a special material having desired pickup efficiency andshedding efficiency for detecting trace amounts of antineoplasticagents, and is provided on a handle having sufficient length so that theuser can swab a surface without physically contacting the surface or theswab. The handle can perform a double function by serving as thecartridge enclosing the test strip, and interior features of the handlecan form the fluid path between the swab and the test strip. A liquid,for example a buffer solution, can be provided on the swab material sothat the user removes a pre-wetted swab to swipe the surface in oneimplementation. In another implementation, the user sprays the surfacewith a liquid and collects this liquid with the swab material. Trisbuffer and ChemoGlo solution are two suitable buffer solutions that canbe implemented in contamination collection devices described herein.

The collection kit can further include a template, guide, orinstructions to delineate a specific dimensional area for testing. Inorder to obtain an accurate test result for contaminants that arehazardous even in trace amounts, a precise method of marking(demarcation) and then performing the sampling procedure (for example,to sample all of the demarcated area and only the demarked area) can bea very important step to ensure an accurate result. There are severalfactors that can be key to obtaining an accurate drug concentrationmeasurement given in the following formula:

$C = \frac{\propto {*A*\eta_{p}*\eta_{e}}}{V_{b}}$where C is the concentration, α is the contamination surface density(ng/ft{circumflex over ( )}2), A is the surface area swabbed and tested,η_(p) is the pick-up efficiency, lie is the extraction from the swabdensity, and V_(b) is the fluid volume of the buffer solution used tohelp extract and carry the contamination to the test strip. A goal ofthe described testing can be to have a high concentration signal withlow variability. Excessive “noise” or variation in the variables maycause the test to either give false positive or false negative results.Test kits described herein can include mechanisms and/or instructions tousers to assist in reducing the variation of each term in the aboveconcentration equation.

After swabbing the surface, the user places the cap over the swab toform a liquid-tight, sealed compartment that encapsulates the swabmaterial and any absorbed liquid. The cap can additionally lock to thehandle. A reservoir in the handle and/or cap can contain a buffer ordiluent solution used as an agent to help remove the particles ofinterest embedded on the swab material into the fluid of the container.The collection device advantageously prevents liquid from spilling andcontaminating surfaces or users, but provides for controlled delivery offluid to a detection device such as a test strip. Fluid can be wickeddirectly from the swab material to the test strip in some embodiments,and in other embodiments fluid can be released from the swab materialalong a fluid path to a receiving zone of an assay test strip.

It will be understood that signals generated by embodiments of lateralflow assay devices described herein can be detected using any suitablemeasurement system, including but not limited to visual inspection ofthe device and optical detection using an optical reader. In one aspect,the testing device can be an immunoassay reader, for example a lateralflow assay and reader device, with an interface that alerts the user tothe presence and/or degrees of contamination. After sample collectionwith the integrated swab material, the assay test strip can be insertedinto a reader to image the indicators on the strip, analyze theimage(s), determine a level of contamination, and report the determinedlevel of contamination to the user. The reader can have more than onemethod of entering data regarding the sample and can have various waysof saving, storing, displaying, uploading and alerting the appropriatepersonnel when unacceptable levels of contamination are detected.

In one example, after detecting contamination in an initial test therecan be several possible next steps. A first option can be to use anothermore sensitive test strip to determine an advanced level of detection. Asecond option can be to use another similar test strip in an area nearthe initial test area to determine the spread of the contamination. Athird option can be to initiate any specified decontamination protocolin the area of the test surface (and potentially surrounding areas). Itwill be understood that some or all of these non-limiting options caninitiated simultaneously or sequentially.

The described swabs, buffer solutions, and test devices can beconfigured to pick up and detect trace amounts of antineoplastic agentsand/or chemotherapeutic drugs in some embodiments. It will beappreciated that the described systems can be adapted to collect anddetect quantities of other biohazardous chemicals, drugs, pathogens, orsubstances in other embodiments. Further, the disclosed systems can beused in forensic, industrial, and other settings.

Although the disclosed detection devices are typically described hereinwith reference to test strips and lateral flow assay reader devices, itwill be appreciated that the described hazardous contaminant detectionaspects described herein can be implemented in any suitable detectionsystem. For example, features described herein can be implemented inreader devices that analyze other types of assays, such as but notlimited to molecular assays, and provide a test result. Further, thefluid including any collected contaminants can be transferred from thecollection device to a centrifuge, spectrometer, chemical assay, orother suitable test device to determine the presence and/orconcentration of one or more hazardous substances in the sample.

Drugs successfully treat many types of illnesses and injuries, butvirtually all drugs have side effects associated with their use. Not alladverse side effects classify as hazardous, however. In the presentdisclosure, the term “hazardous drugs” is used according to the meaningadopted by the American Society of Health-System Pharmacists (ASHP),which refers to a drug as hazardous if studies in animals or humans haveindicated that exposures to them have any one of four characteristics:genotoxicity; carcinogenicity; teratogenicity or fertility impairment;and serious organ damage or other toxic manifestation at low doses inexperimental animals or treated patients.

Although described in the example context of ascertaining theconcentration of hazardous drugs such as antineoplastic agents, it willbe appreciated that the disclosed test strips and reading techniques canbe used to detect the presence and/or concentration of any analyte ofinterest. An analyte can include, for example, drugs (both hazardous andnon-hazardous), antibodies, proteins, haptens, nucleic acids andamplicons.

Various embodiments will be described below in conjunction with thedrawings for purposes of illustration. It should be appreciated thatmany other implementations of the disclosed concepts are possible, andvarious advantages can be achieved with the disclosed implementations.

Overview of Example Contaminant Collection

FIG. 1 illustrates example steps of a testing method 100 using a systemcontaminant collection device according to the present disclosure, suchas but not limited to those shown in FIGS. 2A-2C and 4A-6E. One, some,or all of the depicted blocks of FIG. 1 can be printed as graphicalinstructions on the packaging or instruction materials of an assayand/or collection kit, or can be presented on a graphical user interfaceof a display screen of an assay reader device, a test area terminal, ora personal computing device of the user.

At block 105, the user can identify a sample location and gather testingsupplies including a collection kit and protective wear. The collectionkit can include a collection device including a swab material on anelongate handle, as described herein, for example in a sealed package.In some examples, the swab is pre-wetted with buffer solution andpackaged in a sealed pouch. In some implementations, a removable cap canseal the swab material prior to use. The assay cartridge can form someor all of the handle. The assay cartridge may include an assay devicehoused inside a cartridge having a window or port aligned with areaction zone of the assay device. In one implementation, the assaydevice is a test strip, for example but not limited to a lateral flowassay test strip. Also at block 105 the user can put on clean glovesprior to each sample collection and/or opening of the collection kit,both to protect the user from potential contamination on the surface andto protect the collection device from any contamination on the user'shands. The collection kit can also include a template for demarcatingthe area to be tested on the test surface, though in some examples thetemplate may be provided separately. The collection kit may also includeadditional buffer fluid for wetting the test surface, though in someexamples this can be provided on a pre-moistened swab material.

At block 110, the user can establish a test area on the test surface.For example, the user can place a template over the intended location toclearly demarcate the area that will be swabbed. The template can be aphysical template as shown, or may be provided via augmented reality(e.g., smart glasses, a heads up display, a projection onto the testsurface). Also at block 110 the user can open the collection kitpackaging, including opening the integrated swab and assay cartridge.The test area may be one square foot in some embodiments, for exampledemarcated as a 12 inches by 12 inches (144 square inches) region. Otherexamples can use greater or smaller areas for collection including 10inches by 10 inches, 8 inches by 8 inches, 6 inches by 6 inches and 4inches by 4 inches, non-square rectangular regions (e.g., a 9 inches by16 inches rectangle), and non-rectangular regions (e.g. circles).Different-sized templates may be specified for use with different testsurfaces. The particular template used can be indicated to a readerdevice, for example via a manual user input or via a barcode or otheridentifying pattern on the template scanned by the reader device. Forexample, a template providing a swab area of a 12 inches by 12 inchesregion can be indicated for use in sampling a countertop, while asmaller template demarcating a smaller swab area can be indicated forswabbing an IV pole. The reader device can adjust its test resultcalculations to account for the actual area tested, as indicated by theparticular template used for the sampling procedure.

At block 115, the user can swab the entire test area with thepre-moistened swab. The user can swab the test area using slow and firmstrokes. As shown, the user can methodically pass the swab in straightlines along the height of the test area all the way across the width ofthe test area. In embodiments using augmented reality templates, theuser can be provided with a visual indication of one or more of thealready-swabbed portions of the test region, to-be-swabbed portions ofthe test region, and swab pattern. As the user swabs the surface, theswab material of the collection device can pick up contaminant particlesand/or any buffer liquid provided on the test surface. After swabbing iscomplete, the user can seal the exposed swab material of the collectiondevice, for example by applying a cap that engages with the assaycartridge and/or handle and seals the swab material. Optionally, the capcan include an additional quantity of buffer solution and a mechanismfor releasing this buffer solution onto the swab material to flushcollected contaminants downstream to the assay device.

At block 120, the user can use a timer to allow the sample to developfor a period of time. For example, the sample can develop for about oneminute, about two minutes, about three minutes, about four minutes,about five minutes, about six minutes, or some other amount of time.Other development times are possible. In some embodiments the timer canbe built in to the programming of the reader device that reads theassay. The development time can vary depending on the particular testthat is being performed and the particular operating parameters of theassay device. In some embodiments, at least some liquid may betransferred from the swab material to the assay device during swabbing,and the development time can include some or all of the time taken atblock 115 to swab the surface. In some embodiments, a valve or frangibleseal can isolate the assay device from the collected liquid duringswabbing at block 115, and after completion of the swabbing the user cancause the breaking or opening of this seal to transfer the liquid fromthe swab material to the assay device. In such embodiments, developmenttime may not include any of the swabbing time.

At block 125, the user can insert the assay cartridge into an assayreader device. The assay cartridge can be inserted into the readerdevice prior to or after the sample is developed, depending upon theoperational mode of the device. In some embodiments, the user maysequentially insert multiple cartridges for testing different aspects ofthe test surface or for ensuring repeatability of test results. Althoughthe cartridge shown in block 125 is not depicted with swab material, itwill be appreciated that in some embodiments the integrated swabmaterial may remain affixed to the cartridge as it is inserted (via theend opposite the integrated swab material) into the reader device.

At block 130, the assay reader device reads portions of the insertedcartridge (including, for example, detecting optical signals fromexposed areas of a capture zone of a test strip housed in thecartridge), analyzes the signals to determine optical changes to testzone location(s) and optionally control zone location(s), determines aresult based on the optical changes, and displays the result to theuser. The device can optionally store the result or transmit the resultover a network to a centralized data repository. As illustrated, thedevice displays a negative result for the presence of Doxorubicin in thesample. In other embodiments the device can display a specific detectedconcentration level in the sample and/or determined for the test area,and optionally can display confidence values in the determined result.

After testing the user can dispose of the collection device and assay(for example in compliance with hazardous waste regulations).Optionally, the user can connect the reader device to its power supply,execute any needed decontamination procedures, re-test a decontaminatedsurface, and perform required reporting of the result. Though notillustrated in FIG. 1, further steps can include operating the readerdevice to perform analysis of the test strip. An example of thecartridge inserted into a reader device is shown in FIG. 3A, and anexample of the reader device displaying test results is shown in FIG.3B.

FIGS. 2A-2C show example steps of using a collection device with anintegrated swab and test strip during various portions of the process100. Specifically, FIG. 2A shows a user holding a collection device 200according to one implementation of the present disclosure. Thecollection device includes an integrated swab handle/assay cartridge225. FIG. 2A also shows the user removing a cap 205 from a distal end215 of the integrated swab handle/assay cartridge 225 to expose a swabmaterial 210. This can happen before block 115 of the testing method100. FIG. 2A also shows a window 220 in the integrated swab handle/assaycartridge 225 for viewing a reaction zone of a test strip containedwithin the integrated swab handle/assay cartridge 225. FIG. 2B shows theuser holding the integrated swab handle/assay cartridge 225 with theswab material 210 applied to a test surface 230, for example duringblock 115 of the testing method 100. FIG. 2C shows the user holding thecollection device 200 after completion of the swabbing with the cap 205reapplied, for example after block 115 of the testing method 100.Further details of collection devices with an integrated swab and teststrip are described below.

FIGS. 3A and 3B illustrate an example reader device 300 that can beincluded in or used with hazardous contamination detection kitsdescribed herein. FIG. 3A illustrates the reader device 300 with anassay cartridge 330 inserted into a cartridge receiving aperture 305,and FIG. 3B illustrates the reader device 300 without an insertedcartridge. Examples of the assay cartridge 330 include but are notlimited to the integrated handle and cartridge shown in FIGS. 2A-2C and4A-6E.

The reader device 300 can be an assay reader device having an aperture305 for receiving an assay test strip and cartridge 330. The aperture305 can also be configured to position the test strip so that analytebinding regions are positioned in an optical path of imaging componentslocated inside of the device 300. The device can also use these oradditional imaging components to image a bar code on the cartridge, forexample to identify which imaging techniques and analysis to perform.

Some embodiments of the device 300 can be configured to perform aninitial scan, for example using a bar code scanner to image one or morebar codes. A bar code can identify the type of test to be performed, theperson conducting the test, the location of the test, and/or thelocation in the facility of the test surface (for example pharmacy,nursing area, cabinet #, bed #, chair #, pump #, etc.). After readingthe bar code identifier the cartridge is then inserted into the readeras shown in FIG. 3A. The device 300 can have a button 310 that readiesthe device for use and provides an input mechanism for a user to operatethe device.

The device 300 can also include a display 315 for displayinginstructions and/or test results to the user. After insertion of thetest strip, the device 300 can read a bar code on the assay test stripto identify the name and/or concentration range of the drug. The device300 can image the inserted test strip, and analyze the signalsrepresenting the imaged test strip to calculate results, display theresults to the user, and optionally transmit and/or locally store theresults. The results can be calculated and displayed as contaminationwith an indication of positive or negative (for example, +/−; yes/no;etc.), and/or the actual contamination per area (for example, DrugConcentration=0.1 ng/cm2) and/or per volume (for example, DrugConcentration=3 ng/ml)

Some embodiments of the device 300 may simply display the result(s) tothe user. Some embodiments of the device 300 may also store theresult(s) in an internal memory that can be recalled, for example, byUSB connection, network connection (wired or wireless), cell phoneconnection, near field communication, Bluetooth connection, and thelike. The result(s) can also automatically be logged into the facilityrecords and tracking system. The device 300 can also be programmed toautomatically alert any additional personnel as required, withoutfurther input or instruction by the user. For example, if the device 300reads contamination levels that are above the threshold of human uptakeand considered hazardous to for human contact, a head pharmacist, nurse,manager, or safety officer can be automatically notified with theresults and concentration of contamination to facilitate a rapidresponse. The notification can include location information, such as butnot limited to a geographic position (latitude/longitude) or descriptionof location (Hospital A, Patient Room B, etc.). That response mayinclude a detailed decontamination routine by trained personnel or usinga decontamination kit provided together or separately from the hazardouscontamination detection kit.

In some embodiments, device 300 can be a special-purpose assay readerdevice configured with computer-executable instructions for identifyingtrace concentrations of contaminants in the samples applied to teststrips. Further components of the device 300 are discussed below withrespect to the diagram of FIG. 7.

Overview of Example Collection Devices with Integrated Swab and TestStrip

As described herein, the contaminant collection devices according to thepresent disclosure can be “closed systems,” referring to the transfer offluid from the swab material to the assay test strip via a liquid-tighttransfer mechanism. For example, the swab material and detection device(such as a test strip) can be fluidically coupled together within ahousing to provide a fluid tight seal between the swab material and thetest strip (and any intervening fluid path of the collection device).Beneficially, harmful fluids, drugs, or vapors can be completelycontained within such a collection device and not vented into theatmosphere or spilled during transfer between the collector and testdevice, which would possibly cause harm to the user. Fluid-tight canrefer to being liquid impermeable, gas or vapor impermeable, or both,depending upon the properties of the contaminant that the collection kitis designed to detect. Beneficially, this can provide protection to auser of the kit from the potential contaminants in the fluid of thecollection device.

The various collection devices disclosed herein are described at timesusing relative position terms. As used herein, the “upper” surface of acollection device refers to the surface through which the reaction zoneof the test device is visible. The “lower” surface opposes this uppersurface. The “distal” end refers to the end of the collection devicefrom which swabbing material extends or protrudes. The “proximal” endopposes the distal end, and is typically the end that would bepositioned closest to the user during swabbing. In some cases, theproximal end includes the leading edge or surface during insertion intoa reader device (e.g., the edge or surface that enters the reader devicebefore other edges or surface of the collection device). An “elongate”body of the collection device as described herein refers to the lengthof the body (extending between the proximal and distal ends) beinggreater than a width of the body (extending perpendicularly to thelength along the upper or lower surface). For example, the length of anelongate body may be two times, three times, four times, or five timesgreater than the width (or another multiple of the width, where themultiple is greater than one). It will be understood, however, thatimplementations of the present disclosure are not limited to thespecific shapes, sizes, and configurations of the exampleimplementations described with reference to FIGS. 2A-2C and 4A-6E, andthe present disclosure can be implemented in devices having othersuitable shapes, sizes, and configurations.

A reaction zone of a test device, such as an assay test strip, can bevisible through the housing of a collection device as described herein.Such a reaction zone can be configured to produce anoptically-detectable change in appearance in the presence of a hazardouscontaminant. This change can include one or more optically-detectablelines that develop if the hazardous contaminant is (or is not) presentin the applied sample, as described below.

A test strip can also include a sample receiving zone, for examplepositioned where the fluid path within the collection device isconfigured to provide a liquid sample from the absorbent swab material.The sample receiving zone can evenly distribute the sample and direct itto a downstream region of the test strip. The sample receiving zone canoptionally include compounds (e.g., buffer salts, surfactants, proteins,etc.) that facilitate interaction between the liquid sample andmolecules in other zones. The liquid sample can flow, for example, viacapillary action downstream along a substrate of the test strip towardsthe reaction zone. A conjugate release zone can be disposed along thisfluid path, for example containing diffusibly bound molecules that areconjugated to colored or fluorescent label particles. The term“diffusibly bound” refers to reversible attachment or adsorption of thelabeled conjugate to the conjugate release zone such that the materialmoves with the lateral flow when contacted with the liquid sample. Theconjugate release zone is configured to release the labeled conjugateupon contact with the moving liquid sample. The liquid sample andlabeled conjugate can be carried downstream along the lateral flow pathfrom the conjugate release zone to the reaction zone, where one or moredetection zones (formed as lines in some examples, also referred toherein as a reaction zone) have non-diffusibly bound capture reagentsimmobilized within the zone. The term “non-diffusibly bound” refers toattachment of the capture reagents to the material of the detection zonesuch that the capture reagent is immobilized and therefore does not movewith the lateral flow when contacted with the liquid sample. Incompetitive assay implementations, the labeled conjugate can competewith the target contaminant molecule for binding with the capturereagents, such that a greater intensity of a detection line indicates asmaller quantity of target contaminant. Competitive assayimplementations may be suitable for small molecules, such as someantineoplastic agents. In sandwich assay implementations, the labeledconjugate can bind with a first site of target contaminant and a secondsite of the target contaminant can bind with the capture reagentimmobilized in the detection zone, such that a greater intensity of adetection line indicates a greater quantity of the target contaminant.

FIGS. 4A-4D depict an embodiment of a collection device 400 with anintegrated swab material 435 and test device 430 according to thepresent disclosure. Specifically, FIG. 4A shows a front (distal end),top (upper surface), and side perspective view of the collection device400, and FIG. 4B shows a front, bottom (lower surface), and sideperspective view of the collection device 400. FIG. 4C shows a top, sideperspective view of the collection device 400 without its cap, and FIG.4D shows the top, side perspective view of the collection device 400without its upper cartridge portion to reveal the inner components. Themodel of the collection device 400 depicted in FIGS. 4A-4D cancorrespond to the collection device 200 depicted in FIGS. 2A-2C. FIGS.4A-4D are described together below, except where a specific one of FIGS.4A-4D is noted.

The collection device 400 includes an elongate body 405 that forms anintegrated handle and cartridge. The elongate body 405 can be formedfrom an upper shell and a lower shell coupled together. This elongatebody 405 serves to enclose the test strip 430 and fluid path 495 as wellas provide an elongate handle for a user to grasp while swabbing a testsurface. The elongate body 405 includes an aperture 420 on its uppersurface exposing a detection region of the test strip 430. Signalsgenerated at the detection region of the test strip 430 can be detectedthrough a transparent or translucent material forming a window 425 inthe aperture 420. The window 425 also maintains a sealed compartment forthe test strip 430, which may become saturated with a liquid containinghazardous contaminants. The window 425 may be flat, or may follow thecontours of the aperture 420. On its lower surface, the integratedhandle and cartridge 405 can include a track recess 490 that can engagea correspondingly shaped protrusion or rail of a reader device when theelongate body 405 is inserted into the reader device. The track recess490 can be formed in the lower surface and the proximal end 498 of thecollection device 400. In other embodiments the track recess 490 can bereplaced with a rail or track, with the reader device having acorresponding track recess. Other suitable alignment features can beused in other embodiments. The lower surface can include additionalmechanical features (e.g., grooves, detents, protrusions) that mate withcorresponding features of the reader device.

FIGS. 4A and 4B show a cap 410 secured to the distal end 499 of theelongate body 405. The cap 405 includes a grip tab 415 to facilitate itsremoval by a user. The cap 405 also includes a reattachment clip 411.When the user snaps off the cap for sample collection, the cap can bereattached after use by this small clip. The cap 410 covers the swabmaterial 435, which is visible in FIGS. 4C and 4D and extends beyond thedistal end 499 of the elongate body 405. Some embodiments can include asemi-rigid sheet of material within or along a surface the swab material435, which can assist in sample collection by acting as a squeegeeand/or backer that supports the swab material 435. For example, a ledge440 of the upper surface of the elongate body 405 can counter pressureplaced on the swab material 435 by a test surface during swabbing andkeep the swab material 435 firmly engaged with the test surface. In someembodiments, the cap 410 can be broken away from the elongate body 405,folded at a hinge region to be flush with the bottom of the elongatebody 405, and secured there with mechanical mating features. The cap 410can then be folded back to its original position to re-seal the swabmaterial 435 after swabbing a test surface.

The user can moisten the test surface using a solution, hold theelongate body 405, and pass the swab material 435 along the testsurface, for example as described with respect to FIG. 1. The solutioncan be provided separate from the collection device 400. In thisimplementation, the user may not have to perform steps of extracting thecollected sample from the swab material 435 and homogenizing the sample.Instead, the test strip 430 has been extended along a longitudinal axisof the device in a direction away from the reaction zone and leading toa portion that is widened into the swab material 435, allowing the teststrip 430 to function as a collection device in addition to functioningas a detection device. As such, fluid picked up by the swab material 435is drawn directly into the test strip 430 (which can be a lateral flowassay test strip), for example via capillary action along the fluid path495. In the embodiment of FIGS. 4A-4D, the fluid path 495 is formed bythe continuous material extending from the swab material 435 region tothe test strip 430 region. Absorbed fluid can begin to saturate the teststrip 430 as enough fluid is absorbed by the swab material 435. As such,processing (e.g., binding of any collected contaminants to compounds inor on the test strip 430) can begin to take place even during swabbingof the test surface and development (e.g., the appearance of one or moreoptically-detectable signals (such as lines) at the reaction zone) canoccur (including one or more optically-detectable signals at a testregion if the contents of the absorbed liquid include an analyte ofinterest and/or one or more optically-detectable signals at a controlregion confirming that the test strip 430 functions as intended).Signals generated on the test strip 430 can continue to develop untilrequired processing time for result verification is complete.

In some embodiments the test strip 430 and swab material 435 can be aunitary piece of the same material. In other embodiments the swabmaterial 435 can be a different piece of material, potentially adifferent type of material, affixed to the test strip 430. For example,the swab material 435 can be any suitable material having desired pickupand/or shedding efficiency for a target contaminant, including but notlimited to materials described herein. The test strip 430 may be anysuitable material, including but not limited to materials havingstructures (e.g., fibers and/or channels) to wick fluid via capillaryaction in the direction depicted for the fluid path 495.

FIGS. 5A-5G depict another embodiment of a collection device 500 with anintegrated swab material 535 and a test device 530 according to thepresent disclosure. Specifically, FIG. 5A shows a back (proximal end),top (upper surface), and side perspective view of the collection device500 with a cap 510 in a first orientation 515A, and FIG. 5B shows afront (distal end), top, and side perspective view of the collectiondevice 500 with the cap 510 in a second orientation 515B. FIGS. 5A and5B are described together below, except where a specific one of FIGS. 5Aand 5B is noted.

The collection device 500 includes an elongate body 505 that forms anintegrated handle and cartridge. The elongate body 505 can be formedfrom an upper shell 506A and a lower shell 506B coupled together. Thiselongate body 505 serves to enclose the test strip 530 and fluid path595 as well as provide an elongate handle for a user to grasp whileswabbing a test surface. The elongate body 505 includes an aperture 520on its upper surface exposing a detection region of the test strip 530.Signals generated at the detection region of the test strip 530 can bedetected through a transparent or translucent material forming a window525 in the aperture 520. The window 525 also maintains a sealedcompartment for the test strip 530, which may become saturated with aliquid containing hazardous contaminants. The window 525 may be flat, ormay follow the contours of the aperture 520. On its lower surface, theintegrated handle and cartridge 505 can include a track recess 590 thatcan engage a correspondingly shaped protrusion or rail of a readerdevice when the elongate body 505 is inserted into the reader device.The track recess 590 can be formed in the lower surface and the proximalend 598 of the collection device 500. In other embodiments the trackrecess 590 can be replaced with a rail or track, with the reader devicehaving a corresponding track recess. Other suitable alignment featurescan be used in other embodiments. The lower surface can includeadditional mechanical features (e.g., grooves, detents, protrusions)that mate with corresponding features of the reader device.

FIGS. 5A and 5B show a cap 510 secured to the distal end 599 of theelongate body 505. The cap 510 covers the swab material 535 when appliedand extends beyond the distal end 599 of the elongate body 505. The cap510 includes a swab receiving member 540. In FIG. 5A, the cap 510 is ina first orientation 515A, while in FIG. 5B, the cap 510 is in a secondorientation 515B in which it has been flipped over (e.g., rotated 180degrees around its longitudinal axis) compared to the first orientation515A. As will be described in further detail below, this change inorientation provides certain benefits. In the first orientation 515A,the swab material 535 (visible in FIG. 5A through the cap 510) abuts asurface of the swab receiving member 540, thereby preventing the distalend 599 of the elongate body 505 from extending fully into the cap 510.This protects the swab material 535 from contamination during shipmentand storage. The user may receive the device with the cap in the firstorientation 515A, remove the cap 510, perform swabbing as describedherein, and then reapply the cap in the second orientation 515B in whichthe cap is rotated 180 degrees from the position it was in when it wasfirst attached to the device. In the second orientation 515B, the swabmaterial 535 (not visible in FIG. 5B) is fully received by the swabreceiving member 540, and the distal end 599 of the elongate body 505extends fully (e.g., to its maximum possible distance) into the cap 510.This flushes the swab material 535 with a solution stored in the cap asthe swab material breaks the seal containing the solution. It will beunderstood that the cap 510 may not include a swab receiving member 540in some cases, or may include a swab receiving member 540 that is shapedand sized differently than in this example implementation. In someimplementations, the cap 510 includes a tab 555 that engages a detent550 on the upper surface of the elongate body 505. Further details ofthe structure of the cap 510 and its orientations are described withrespect to FIGS. 5E-5F.

FIG. 5C shows a top view of the collection device 500 without its uppercartridge portion 506A (with only the lower cartridge portion 506B) toreveal the inner components. FIG. 5C also depicts the collection device500 without the cap 510, illustrating how the swab material 535 extendsfrom the distal end 599 of the elongate body 505 in a direction awayfrom a reaction zone of the test strip 530, and depicting how the swabmaterial 535 can have a tapered distal end 536. Some embodiments caninclude a semi-rigid sheet of material within or along a surface theswab material 535, which can assist in sample collection by acting as asqueegee and/or backer that supports the swab material 535. FIG. 5Dshows the swab material 535, a retaining member 560 configured to retainthe swab material 535, and the test strip 530. FIGS. 5C and 5D aredescribed together below, except where a specific one of FIGS. 5C and 5Dis noted.

As shown in FIG. 5C, the test strip 530 is housed in an enclosure 570 ofthe elongate body 505. The enclosure 570 can be considered as theinterior cavity of the elongate body 505, formed by interior surfaces ofthe upper cartridge portion 506A, lower cartridge portion 506B, andretaining member 560. The enclosure 570 can be substantially sealed, forexample in a fluid-tight manner, within the elongate body 505.“Substantially sealed” refers to how the enclosure 570 is designed toprevent egress of potentially contaminated fluid from its interior, butstill includes the fluid path 595 that allows passage of fluid from theswab material 535 into the enclosure 570 to contact the test strip 530.For example, the enclosure 570 can have a fluid-tight seal along a seamor junction between the upper cartridge portion 506A and lower cartridgeportion 506B, and can have a fluid-tight seal along a seam or junctionat a distal aperture of the elongate body 505 between the uppercartridge portion 506A, the lower cartridge portion 506B, and theretaining member 560. The channel 565 can enable fluid in the swabmaterial 535 to flow to the test strip 530. The cap 510 (not pictured inFIGS. 5C and 5D) can complete the seal around the enclosure 570 bypreventing egress of liquid from the swab material 535 into theenvironment of the collection device 500.

The retaining member 560 couples the swab material to the elongate body505 and also provides a fluid path 595 between the swab material 535 andthe test strip 530. Specifically, the retaining member 560 includes adistal collar 563 forming a recess 564 that holds a proximal portion ofthe swab material 535. The retaining member can include a fluid transfermember 561 that extends away from the distal collar 563 and forms achannel 565 leading from the recess 564 to an aperture 562 disposedadjacent to the test strip 530. It will be understood that the retainingmember 560 is not limited to the specific configuration described withrespect to this example, and can be implemented using differentstructures that provide a fluid pat 595 between the swab material 535and the test strip 530. As described in more detail below with respectto FIG. 5G, when the cap 510 is pressed onto the elongate body 505 inthe second orientation 515B, this can cause compression of the swabmaterial 535 (and can release additional fluid into the swab material535), pushing fluid through the channel 565 in the direction depictedfor the fluid path 595. The distal collar 563 can include a contouredsurface 566 that engages with (and in some examples forms a seal with)internal features of the cap 510. Thus, the retaining member 560 securesthe swab material 535, provides a fluid path 595 along which fluid cantravel from the swab material 535 to the test strip 530, and also formsa seal to enclose the fluid path 595 leading into the enclosure 570.

The user may receive the collection device 500 packaged with the cap 510applied in the first orientation 515A. As shown in FIG. 5A, in thisfirst orientation 515A, the cap 510 may not engage the detent 550 on theupper surface of the elongate body 505. The swab material 535 can bepre-moistened, for example with a liquid designed to optimize pickupefficiency of the target contaminant from a test surface. In the firstorientation 515A, the cap 510 can form a seal with the upper and lowercartridges 506A, 506B to maintain the swab material 535 in itspre-moistened condition. The user can remove the cap 510 and pass themoistened swab material along the test surface, for example as describedabove with respect to FIG. 1. After the collection procedure iscomplete, the user can put the cap 510 back onto the elongate body 505in the second orientation 515B. In this second orientation 515B, asdescribed in further detail below, additional fluid stored within thecap is released onto the swab material 535, causing it to over-saturateand release fluid along the fluid path 595 through the channel 565 tothe test strip 530.

FIGS. 5E-5F illustrate how the cap 510 is configured to both compressthe swab material 535 and also flush additional solution through theswab material 535 after the swab material 535 has been used to collect asample. FIG. 5E shows a perspective view of the cap 510 and the swabreceiving member 540 positioned within the interior of the cap 510. Theswab receiving member 540 has a lip 543 that engages with an interiorwall of the cap 510. The lip 543 can include a contoured surface 548shaped to match the shape of contoured surface 566 of the swab retainingmember 560. A gasket 544 is disposed along the contoured surface 566 toseal with the contoured surface 566. In the depicted example, the gasket544 and contoured surface 548 are arch-shaped, however the particulardesign can vary in other implementations.

A wall 546, formed in this example as a rectangular tube, extends awayfrom the lip 543 to form a slot 542 sized and positioned to receive theswab material 535 when the cap 510 is applied to the elongate body 505in the section orientation 515B. The wall 546 may assume other geometricconfigurations in other designs such that the shape of the slot 542generally corresponds to the exterior shape of the swab material 535. Insome implementations, the slot 542 may taper along its length toencourage liquid to move backwards through the swab material 535 (e.g.,in a direction from the distal end 599 of the collection device 500toward the proximal end 598 of the collection device 500) as the swabmaterial 535 is inserted into the slot 542.

An aperture 545 is formed at a distal end of the slot 542. In FIG. 5E,the aperture 545 is covered by a frangible seal 541. The frangible seal541 can be formed from a liquid-tight material that may be pierced,broken, or detached from the wall 546 upon application of a certainamount of force from the swab material 535 (as described with moredetail with respect to FIG. 5G). When the seal 541 is opened, fluid canflow from the reservoir 513 into the slot 542 (and any swab material 535positioned in the slot 542).

The swab receiving member 540 may be a separately manufactured componentfrom the body of the cap 510, and can be inserted into the cap 510through its proximal aperture 514. The cap 510 can have a ledge 511 thatretains the swab receiving member 540 in its proper position within thecap 510 (e.g., positioned so that the swab material 535 will be receivedin the slot 542). For example, the reservoir 513 of the cap 510 can befilled with liquid, for example a buffer solution designed to flushcollected contaminant off of the swab material 535, and then the swabreceiving member 540 with the frangible seal 541 sealing the aperture545 can be inserted into the cap 510. This can seal the liquid in thereservoir 513 of the cap until the frangible seal 541 is broken. Once inplace, the swab receiving member 540 can be affixed in place withsuitable means including but not limited to pressure, adhesive,ultrasonic welding, and mechanical fasteners.

FIG. 5E also depicts the structure of the tab 555 in greater detail. Thetab 555 includes a protrusion 558 on its surface that faces the uppercartridge portion 506A. The protrusion 558 has a sloped or curvedsurface 556 that faces proximally as the cap 510 is inserted onto theelongate body 505 and a flat surface 557 that faces distally as the cap510 is inserted onto the elongate body 505. This shape can correspond tothe shape of the detent 550 on the elongate body 505 in order to snapthe cap 510 into place and/or lock the cap 510 to the elongate body 505when in the second orientation 515B. It will be understood that otherconfigurations of the tab 555 can be suitably implemented in embodimentsof the present disclosure.

FIG. 5F shows a cross-sectional view of the distal end 599 of thecollection device 500 with the swab material 535 omitted for ease ofviewing other components. In this view, the cap 510 is fully applied tothe elongate body 505 in the second orientation 515B. Thiscross-sectional view illustrates how the recess 564 of the retainingmember 560 tapers (e.g., has an increasingly smaller cross section)towards the aperture 545. This cross-sectional view also illustrates howthe recess 564 of the retaining member 560 aligns with the slot 542 ofthe swab receiving member 540 when the cap 510 is applied to theelongate body 505 in the second orientation 515B. The reservoir 513 hasa height H along a dimension between the upper surface and the lowersurface of the elongate handle 505. This height H can correspond to theheight of the elongate handle 505 along the same dimension. Asillustrated in FIG. 5F, the slot 542 and recess 564 are verticallyoffset (e.g., not centered) along the height H. This results in amismatch between the swab material extending from the recess 564 and theslot 542 when the cap is in the first orientation 515A, such that theswab material 535 abuts the lip 543 rather than entering the slot 542.This can prevent the swab material 535 from breaking the frangible seal541 when the cap is applied in the first orientation 515A. The verticaloffset of the recess 564 can be the same as the vertical offset of theslot 542 along the height H so that they align with one another when thecap 510 is applied to the elongate body 505 in the second orientation515B.

In this example, the cap 510 has a rectangular cross section, and thesecond orientation 515B represents reapplication of the cap after a 180degree rotation (about the cap's longitudinal axis around its lengthdimension) of the cap 510 relative to the first orientation 515A. Otherimplementations can structure the cap 510 and the distal end 599 of theelongate body 505 so that other rotations from the first orientation515A yield the second orientation 515B. For example, in anotherimplementation the cap 510 may have a square, circular, or otherrotationally symmetric cross section, and can be rotated any number ofdegrees less than 360 degrees to switch to the second orientation 515Bfrom the first orientation 515A. FIG. 5F also illustrates how the gasket544 can seal the negative space formed by the joining of the slot 542and the recess 564. Beneficially, this can isolate any contaminantscollected by the swab material 535 within the sealed enclosure 570,protecting the environment and/or user of the collection device 500 fromexposure to potentially hazardous compounds.

FIG. 5G shows a cross-sectional view of the distal end 599 of thecollection device 500 with the swab material 535, and the cap 510 fullyapplied to the elongate body 505 in the second orientation 515B. FIG. 5Galso includes a legend 580 depicting dimensions corresponding to theheight (H), length (L), and width (W) of the collection device 500 asshown in FIGS. 5F-5G. This cross-sectional view illustrates thepositioning of the swab material 535 relative to the receiving member540. FIG. 5G depicts the swab material 535 in its original, uncompressedshape, and as such it appears to spatially overlap with the receivingmember 540 due to the taper of the slot 542. It will be appreciated thatin use the swab material 535 would be compressed to correspond to thetaper of the slot 542. In addition, the length of the swab material 535is greater than the combined length of the slot 542 and the recess 564,such that the tapered distal end 536 extends distally beyond theposition of the frangible seal 541. This can cause the frangible seal541 to break or otherwise open, releasing the fluid of the reservoir 513into the swab material 535. The tapered distal end 536 can alsofacilitate insertion of the swab material 535 into the tapered slot 542.As such, the application of the cap 510 in the second orientation 515B,as shown in FIG. 5G, beneficially provides both flushing of the swabmaterial 535 (by breaking the seal 541) and compression of the swabmaterial 535 to encourage flow of fluid (and any collected contaminants)through the channel 565 and onto the test strip 530.

As described above, the test strip 530 can be a lateral flow assay teststrip, which may have a predetermined development time for viewing ofresults of the test. In some embodiments, this development time canbegin upon application of the cap 510 in the second orientation 515B,which causes liquid to flush the swab material 535 and carry anycollected sample to the test strip 530. After the development time, auser and/or reader device can view the detection region of the teststrip 530 to determine the presence and/or concentration of the targetcontaminant at the test surface, for example based on the number and/orintensity of lines that develop in the detection region.

FIGS. 6A-6E depict another embodiment of a collection device 600 with anintegrated swab material 635 and test device 630 according to thepresent disclosure. Specifically, FIG. 6A shows a front (distal end),top (upper surface), and side perspective view of the collection device600 with a cap 610 applied, and FIG. 6B shows the front, top, and sideperspective view of the collection device 600 with the cap 610 removedto expose the swab material 635. FIGS. 6A and 6B are described togetherbelow, except where a specific one of FIGS. 6A and 6B is noted.

The collection device 600 includes an elongate body 605 that forms anintegrated handle and cartridge. The elongate body 605 can be formedfrom an upper shell 606A and a lower shell 606B coupled together. Thiselongate body 605 serves to enclose the test strip 630 and fluid path aswell as provide an elongate handle for a user to grasp while swabbing atest surface. The elongate body 605 includes an aperture 620 on itsupper surface exposing a detection region of the test strip 630. Signalsgenerated at the detection region of the test strip 630 can be detectedthrough a transparent or translucent material forming a window 625 inthe aperture 620. The window 525 also maintains a sealed compartment forthe test strip 630, which may become saturated with a liquid containinghazardous contaminants. The window 625 may be flat, or may follow thecontours of the aperture 620. On its lower surface, the integratedhandle and cartridge 605 can include a mechanical feature (not shown)that can engage a correspondingly shaped mechanical feature of a readerdevice when the elongate body 605 is inserted into the reader device.

The swab material 635 is secured by a retaining member 660. A collar 650secures the retaining member 660 to the elongate body 605. As describedwith respect to FIGS. 6D and 6E, the collar 650 can be slidably engagedwith the elongate body 605 such that a user can move the collar 650 (andthe attached retaining member 660 and optionally the cap 610) toward theproximal end 698 of the collection device. In some embodiments, a usercan press a button 651 to release the collar 650, retaining member 660,and swab material 635 (optionally with the cap 610 attached) from theelongate body 605. The user can separate the collection device 600 intoa collection portion (including the collar 650, retaining member 660,swab material 635, and optionally the cap 610) and a test portion(including the elongate body 605 and the test strip 630). Beneficially,this can allow the user to connect the collar 650 to a differentelongate body 605A containing another test strip 630A (not illustrated),for example to apply the same collected sample to multiple test strips.As described in more detail with respect to FIGS. 6D and 6E, one or bothof the collection portion and the test portion can have sealing featuressuch that their interior enclosures are sealed during the decoupling ofthe collection portion from the test portion. Beneficially, this canprevent potentially hazardous contamination from spilling during thedecoupling and as the separated portions are handled, and can maintainany additional collected sample within the collection portion.

FIG. 6C shows a top view of the collection device 600 without its uppercartridge portion 606A (with only the lower cartridge portion 606B) toreveal the inner components. FIG. 6C also depicts the collection device600 with the cap 610 removed, illustrating how the swab material 635extends from the distal end 699 of the elongate body 605. Someembodiments can include a semi-rigid sheet of material within or along asurface the swab material 635, which can assist in sample collection byacting as a squeegee and/or backer that supports the swab material 635.The retaining member 660 couples the swab material 635 to the elongatebody 605.

As shown in FIG. 6C, the test strip 630 is housed in an enclosure 670 ofthe elongate body 605. The enclosure 670 can be considered as theinterior cavity of the elongate body 605, formed by interior surfaces ofthe upper cartridge portion 606A, lower cartridge portion 606B, andretaining member 660. The enclosure 670 can be substantially sealed, forexample in a fluid-tight manner, within the elongate body 606.“Substantially sealed” refers to how the enclosure 670 is designed toprevent egress of potentially contaminated fluid from its interior, butstill includes the fluid path (a second portion 695B which is depictedin FIGS. 6C and 6E) that allows passage of fluid from the swab material635 into the enclosure 670 to contact the test strip 630. For example,the enclosure 670 can have a fluid-tight seal along a seam or junctionbetween the upper cartridge portion 606A and lower cartridge portion606B, and can have a fluid-tight seal along a seam or junction at adistal aperture of the elongate body 605 between the upper cartridgeportion 606A, the lower cartridge portion 606B, and the retaining member660.

A dosing mechanism 680, described in further detail with respect toFIGS. 6D and 6E, selectively passes fluid eluted from the swab material635 along the second portion 695B of the fluid path to the test strip630. The dosing mechanism 680 can be open to receive fluid from the swabmaterial 635 and can seal the second portion 695B of the fluid path inthe enclosure 670 when in a “fluid entry” configuration. The dosingmechanism 680 can also seal off (e.g., fluidically isolate) the swabmaterial 635 from the enclosure 670 and open the fluid path into theenclosure 670 when in a “fluid delivery” configuration.

FIG. 6C also depicts the swab receiving member 640 of the cap 610. Theswab receiving member 640 is sized and positioned to receive the swabmaterial 635 when the cap 610 is applied to the retaining member 660. Areservoir 613 formed in the cap 610 can hold a liquid, for example abuffer solution designed to promote shedding of collected contaminantsfrom the swab material 635. When a user actuates a pump button 611, thiscan break a frangible seal 641 (visible in FIGS. 6D and 6E) of the swabreceiving member 640, thereby saturating the swab material 635. It willbe understood that embodiments of the present disclosure can beimplemented with a cap that does not include a swab receiving memberand/or reservoir in the cap.

The user may receive the collection device 600 packaged with the cap 610applied. The swab material 635 can be pre-moistened, for example with aliquid designed to optimize pickup efficiency of the target contaminantfrom a test surface. The cap 610 can include gasket(s) or other sealingmechanisms to maintain the pre-moistened condition of the swab material635 prior to use. The user can remove the cap 610 and pass the moistenedswab material 635 along the test surface, for example as described abovewith respect to FIG. 1. After the collection procedure is complete, theuser can put the cap 610 back onto the retaining member 660 and activatethe pump button 611 to flush any collected contaminants from the swabmaterial 635.

FIG. 6D depicts a cross-sectional view of the distal end 699 of thecollection device 600 showing the collar 650 in a first position and thedosing mechanism 680 in the fluid entry configuration, and FIG. 6Edepicts a cross-sectional view of the distal end 699 of the collectiondevice 600 showing the dosing mechanism 680 in the fluid deliveryconfiguration.

FIGS. 6D and 6E depict additional details of the cap 610, including aseal 612 in the pump button assembly. The cap 610 also includes thefrangible seal 641 positioned between the reservoir 613 and the swabmaterial 635. The pump button 611 can be a deformable material thatallows it to be compressed into a pump chamber 614 of the push buttonassembly, for example by a finger of a user. The user can depress thepump button 611 a number of times to increase the pressure within thereservoir 613, causing the seal 641 to break. The pump button 611 caninclude vents (e.g., small apertures) to allow air to be drawn into thepump chamber 614 when the pump button 611 is released. The filter 612can be a gas-permeable, liquid impermeable material to prevent anyliquid within the reservoir 613 from being released into the environmentof the collection device 600. In some embodiments, the filter 612 can behydrophobic. The user may depress the pump button 611 an additionalnumber of times to flush fluid through the swab material.

FIGS. 6D and 6E also depict additional details of the retaining member660. The swab material 635 is retained in a collar 664 of the retainingmember 660. The retaining member 660 forms sample receiving bladder 663on the proximal side of the collar 664 for containing any fluid elutedfrom the swab material 635 along the first portion 695A of the fluidpath between the swab material 635 and the test strip 630. The firstportion 695A of the fluid path extends between the proximal side of theswab material 635 and the distal end of the dosing mechanism 680. Thecollar 664 includes apertures 661 that allow fluid to pass from the swabmaterial 635 into the sample receiving bladder 663. A number of fins 662are disposed on the proximal surface of the collar 664 along supportstructures 665 that extend between (and form) the apertures 661.Beneficially, the fins 662 can promote turbulence in fluid eluted fromthe swab material 635 into the sample receiving bladder 663, mixing thefluid into a homogenous solution.

After depressing the pump button 611 the desired number of times toflush the swab material 635, the sample receiving bladder 663 contains asubstantially homogenous solution including any collected contaminants.This solution can be provided to the test strip 630 via the dosingmechanism 680. For example, the user can slide the collar 650 proximallyalong the elongate body 605 in the direction of arrow 697. This can alsocause movement of the retaining member 660 that is coupled to the collar650 relative to the elongate body 605, where the motion of the retainingmember 660 is toward the proximal end 698 of the elongate body 605. Atubular end 652 of the retaining member 660 can slide into acorresponding recess 654 surrounding the dosing mechanism 680, until thecollar 650 has transitioned from the first position shown in FIG. 6D tothe second position shown in FIG. 6E.

The dosing mechanism 680 can include a tubular body 681 forming aninterior lumen 686. A piston 682 can be disposed within the interiorlumen 686 for selectively sealing and opening the dosing mechanism. Thepiston 682 can have an enlarged distal end 683 having a diameter thatsubstantially corresponds to the interior diameter of the interior lumen686, such that the enlarged distal end 683 can both prevent fluid fromentering the distal aperture of the interior lumen 686 and push fluidthrough the proximal aperture of the interior lumen 686. The piston 682can have an elongate length extending between the enlarged distal end683 and a proximal seal 684. The proximal seal 684 can be formed as adish-shaped member that seals the proximal aperture of the interiorlumen 686 when in the configuration shown in FIG. 6D. The piston 682 canbe biased in a position that causes the proximal seal 684 to seal theproximal aperture, for example by a spring 685 or other biasing element(e.g., shape memory alloy, magnets).

The enlarged distal end 683 can be spring-loaded and intended to pushthrough a pre-slit valve. The pre-slit valve can be connected to theretaining member 660 assembly as a seal, while the enlarged distal end683 is part of the cartridge assembly. This action can dose the correctvolume (e.g. 75 microliters plus or minus 50-150 microliters, in someimplementations) through and onto the strip. The collar 650 can bebiased toward the retaining member 660 so that releasing its lockingfeature and sliding it away from the retaining member 660 would releasethe assembly of the retaining member 660 from the cartridge. The collar650 can have connections to the enlarged distal end 683 closer to theproximal seal 684 which can control its movement.

Overview of Example Assay Reader Devices and Operations

FIG. 7 illustrates a schematic block diagram of one possible embodimentof components of an example assay reader device 700. The components caninclude a processor 710 linked to and in electronic communication with amemory 715, working memory 755, cartridge reader 735, connectivitymodule interface 745, and display 750.

Connectivity module 745 can include electronic components for wiredand/or wireless communications with other devices. For example,connectivity module 745 can include a wireless connection such as acellular modem, satellite connection, or Wi-Fi, or via a wiredconnection. Thus, with connectivity module 745 the assay reader devicecan be capable of sending or uploading data to a remote repository via anetwork and/or receiving data from the remote repository. As such, thetest data of such assay reader devices can be stored and analyzed, aloneor in the aggregate, by remote devices or personnel. A module having acellular or satellite modem provides a built-in mechanism for accessingpublicly available networks, such as telephone or cellular networks, toenable direct communication by the assay reader device with networkelements or other testing devices to enable electronic test resulttransmission, storage, analysis and/or dissemination without requiringseparate intervention or action by the user of the device. In someembodiments connectivity module 745 can provide connection to a clouddatabase, for example a server-based data store. The cloud basedconnectivity module can enable ubiquitous connectivity of assay readerdevices without the need for a localized network infrastructure.

The cartridge reader 735 can include one or more photodetectors 740 forreading an assay held in an inserted cartridge and optionally anyinformation on the inserted cartridge, for example a barcode printed onthe cartridge, and one or more light emitting devices 742 forilluminating the inserted cartridge at one or more wavelengths of light.The cartridge reader 735 can send image data from the one or morephotodetectors to the processor 710 for analysis of the image datarepresenting the imaged assay to determine a test result of the assay.The cartridge reader 735 can further send image data from the one ormore photodetectors representing the imaged cartridge for use indetermining which one of a number of automated operating processes toimplement for imaging the assay and/or analyzing the image data of theassay. The photodetector(s) 740 can be any device suitable forgenerating electric signals representing incident light, for example aPIN diode or array of PIN diodes, a charge-coupled device (CCD), or acomplementary metal oxide semiconductor (CMOS) sensor, to name a fewexamples. The cartridge reader 735 can also include a component fordetecting cartridge insertion, for example a mechanical button,electromagnetic sensor, or other cartridge sensing device. An indicationfrom this component can instruct the processor 710 to begin an automatedassay reading process without any further input or instructions from theuser of the device 700.

Processor 710 can be configured to perform various processing operationson image data received from the cartridge reader 735 and/or connectivitymodule interface 745 in order to determine and store test result data,as will be described in more detail below. Processor 710 may be ageneral purpose processing unit implementing assay analysis functions ora processor specially designed for assay imaging and analysisapplications. The processor 710 can be a microcontroller, amicroprocessor, or ASIC, to name a few examples, and may comprise aplurality of processors in some embodiments.

As shown, the processor 710 is connected to a memory 715 and a workingmemory 755. In the illustrated embodiment, the memory 715 stores testresult determination component 725, data communication component 730,and test data repository 705. These modules include instructions thatconfigure the processor 710 of device 700 to perform various moduleinterfacing, image processing, and device management tasks. Workingmemory 755 may be used by processor 710 to store a working set ofprocessor instructions contained in the modules of memory 715.Alternatively, working memory 755 may also be used by processor 710 tostore dynamic data created during the operation of device 700.

As mentioned above, the processor 710 may be configured by severalmodules stored in the memory 715. The test result determinationcomponent 725 can include instructions that call subroutines toconfigure the processor 710 to analyze assay image data received fromthe photodetector(s) 740 to determine a result of the assay. Forexample, the processor can compare image data to a number of templatesor pre-identified patterns to determine the test result. In someimplementations, test result determination component 725 can configurethe processor 710 to implement adaptive read processes on image datafrom the photodetector(s) 740 to improve specificity of test results andto reduce false-positive results by compensating for background andnon-specific binding.

The data communication component 730 can determine whether a networkconnection is available and can manage transmission of test result datato determined personnel and/or remote databases. If the device 700 isnot presently part of a network, the data communication component 730can cause local storage of test results and associated information inthe test data repository 705. In some case, the device 700 can beinstructed to or automatically transmit the stored test results uponconnection to a network. If a local wired or wireless connection isestablished between the device 700 and another computing device, forexample a hospital, clinician, or patient computer, the datacommunication component 730 can prompt a user of the device 700 toprovide a password in order to access the data in the repository 705.

The processor 710 can be configured to control the display 750 todisplay captured image data, imaged barcodes, test results, and userinstructions, for example. The display 750 may include a panel display,for example, a LCD screen, LED screen, or other display technologies,and may implement touch sensitive technologies.

Processor 710 may write data to data repository 705, for example datarepresenting captured images of assays, instructions or informationassociated with imaged assays, and determined test results. While datarepository 705 is represented graphically as a traditional disk device,those with skill in the art would understand that the data repository705 may be configured as any storage media device. For example, datarepository 705 may include a disk drive, such as a hard disk drive,optical disk drive or magneto-optical disk drive, or a solid statememory such as a FLASH memory, RAM, ROM, and/or EEPROM. The datarepository 705 can also include multiple memory units, and any one ofthe memory units may be configured to be within the assay reader device700, or may be external to the device 700. For example, the datarepository 705 may include a ROM memory containing system programinstructions stored within the assay reader device 700. The datarepository 705 may also include memory cards or high speed memoriesconfigured to store captured images which may be removable from thedevice 700.

Although FIG. 7 depicts a device having separate components to include aprocessor, cartridge reader, connectivity module, and memory, oneskilled in the art would recognize that these separate components may becombined in a variety of ways to achieve particular design objectives.For example, in an alternative embodiment, the memory components may becombined with processor components to save cost and improve performance.

Additionally, although FIG. 7 illustrates a number of memory components,including memory 715 comprising several modules and a separate memory755 comprising a working memory, one of skill in the art would recognizeseveral embodiments utilizing different memory architectures. Forexample, a design may utilize ROM or static RAM memory, internal memoryof the device, and/or an external memory (e.g., a USB drive) for thestorage of processor instructions implementing the modules contained inmemory 715. The processor instructions may be loaded into RAM tofacilitate execution by the processor 710. For example, working memory755 may comprise RAM memory, with instructions loaded into workingmemory 755 before execution by the processor 710.

Overview of Example Networked Testing Environment

Aspects of the present disclosure relate to a contamination test datamanagement system. There are drug preparation systems, surfacecontamination tests, and healthcare worker safety procedures in thehospital and other healthcare delivery environments. These three areasare connected only to the extent that they have a common goal: to reduceor eliminate healthcare worker exposure to hazardous drugs, and toensure patients are provided correct drug doses. The described hazardouscontamination detection kits, systems and techniques improve uponexisting approaches by linking these three areas, sensing patterns andtrends, and targeting worker feedback and training. By creating andanalyzing associations between data regarding dose preparation,personnel activities, and contamination test results, the disclosedsystems can provide information to healthcare workers and managementtargeted at risk identification, feedback, and training. A beneficialoutcome can include behavioral and/or workflow changes to reduceexposure risk in the test areas.

There are several existing solutions for assisting with pharmacy (orother clinical setting) drug preparation workflow. Each of these systemsis designed to enhance patient safety through automated preparation orverification steps in compounding drugs. These systems are often usedwith hazardous drugs, such as chemotherapy agents, because there islittle room for error with these drugs due to the health risks ofexposure to even trace amounts. One such system performs automated dosecalculation, weight-based (gravimetric) preparation and verification,integrated drug and consumable barcode verification, real-time automateddocumentation of the compounding process, and step-by-step compoundingguidance. Other examples can employ a camera that captures images ofproducts used in dose preparation and optionally an integrated weighingscale design with step-by-step guidance and automatic documentation.

While these systems help automate several aspects of drug preparation,they do not address pre- and post-preparation issues in the pharmacy,such as managing data associated with surface contamination testing (forexample, floors, walls, hoods, etc.). They also do not manage dataassociated with air testing, nor data from testing individuals viafingertip, urine, blood or any other personal exposure monitoring.

Surface wipe tests are available from companies such as ChemoGLO™ whichprovide quantitative analysis of the antineoplastic agents5-fluorouracil, ifosfamide, cyclophosphamide, docetaxel and paclitaxel.An example existing kit contains enough materials to conduct six surfacewipes. The wipes and samples are sent to an outside laboratory, andreports are provided back to the test location within three to fourweeks. Such tests and delayed reports are disconnected processes fromday to day activities in the pharmacy.

Hazardous drugs, particularly chemotherapy drugs, are known tocontaminate surfaces and air in pharmacies and other patient caresettings, which presents a significant health risk to pharmacy and otherhealthcare workers. Further, the United States Pharmacopeia (Cpater 797,28th Rev) recommends sampling of surfaces for contamination withhazardous drugs at least every six months. With improved testingtechnology, better feedback and improved outcomes, the frequency oftesting is expected to become a more routine activity.

FIG. 8 depicts a high level schematic block diagram of an examplenetworked test system environment 800. Hazardous contamination detectionkits described herein can be used in the networked test systemenvironment 800 to improve contamination detectin, risk identification,feedback, and training. The networked environment 800 includes a userinterface 805, dose preparation system 820, surface contamination test825, and reporting system 815 in network communication with a centralserver 810 (and/or one another) via a network. The network can be anysuitable data transfer network or combination of networks includingwired networks and/or wireless networks such as a cellular or otherpublicly accessible network, WiFi, and the like.

The user interface 805 supports system interaction by the test operatorand can be located in the work area, for example in or near the testingenvironment. This facilitates interaction without the test operatorhaving to remove and reapply personal safety equipment in order to usethe system.

The dose preparation system 820 can be hardware associated with agravimetric dose preparation system, a scale, robotics, or devices thatare designed to assist in the preparation of safe drug doses for thepatient.

The surface contamination test 825 can include a local test processingsystem which is in network communication with at least the centralserver 810. For example, the local test processing system can be theassay reader device 800 of FIG. 8.

Central server 810 can implement the algorithms, decisions, rules, andheuristics involved with management of contaminant testing data, and canstore data (individual and aggregate), handle data input and/or output,generate reports, provide the user interface, and the like. Thoughreferred to as a central server, these functions could be carried out ina distributed fashion, virtually, in any location.

The reporting user interface 815 can provide raw and processed data tothe user or safety manager regarding the relationship between activitiesin the pharmacy and test results.

In some implementations, the above descriptions apply to tests that areperformed immediately in a pharmacy, hospital, or other clinicalsetting. However, the described testing is not limited to architectureswhere instant, immediate, or real-time connectivity is available. Forexample, if a local wipe test processing system is not available, datafrom a remote system can be transmitted to the central server using anynumber of methods. Results from tests may be fed in to an interfacemanually, electronically encoded, or in machine readable format. Datanetworks (e.g., internet, wireless, virtual private, cloud-based) can beused to input data from a remote lab (outside the pharmacy, hospital, orclinic) that performs testing either immediately or at a later time. Themain difference between immediate local contamination detection versusremote testing is a potential time delay. As described above, currentcontaminant detection occurs in a two-step process with the stepsperformed at different locations. First, collection happens at site ofpossible contamination. Collection occurs a time A. Second, detection ofthe contamination occurs in a laboratory facility geographicallyseparate from the contamination. Detection occurs at a time B, which isweeks or even months after collection occurred. The present disclosureprovides a system including collection device and detection device inone kit. Using the disclosed kit, collection and detection occur at thesite of possible contamination, and detection occurs within minutes ofcollection. For example, collected fluid can be provided onto an assayimmediately (for example, within seconds such as but not limited towithin 1, 2, 3, 4, 5, 10, or 15 seconds) after agitation of the fluidwithin a container as described herein. The collected fluid can beprovided to the assay for up to 3 hours (360 minutes) after agitation insome embodiments. In some embodiments, instructions for use include arecommendation to the user not to apply the collected fluid to the assaymore than 3 hours after collection because accuracy may decrease after 3hours. After the fluid is added to the assay it can take around fiveminutes to fully develop in some non-limiting examples. In oneadvantageous implementation, the assay is read by a detection systemaround the time of its complete development. As such, the disclosed kitscan provide test results indicating the presence, absence, and/or degreeof contamination between 2-365 minutes after completion of samplecollection, in some embodiments. Laboratory testing of embodiments oftest kits described herein has demonstrated that reliable results can beobtained within about 5 minutes of completion of sample collection, andin some cases in as little as 2 minutes of completion of samplecollection. This represents a dramatic improvement in the time to obtaina test result indicating the presence, absence, and/or degree ofcontamination of a hazardous drug over prior systems.

Embodiments of the system 800 described herein directly link activitiesperformed in the test environment to test results. For example, thesystem 800 can directly link contaminant test results to when activities(for example, during antineoplastic drug preparation, dosing, and thelike) were performed, who performed these activities (for example,through authentication), where the activities occurred (which hood,nearby floor, air test), and other events (such as spills, wasting ofmaterials, or improper waste disposal) which can be manually orautomatically recorded. In some embodiments, the central server 810 canperform analysis of the related information to identify trends inhazardous contamination levels, and can output recommendations forpreventing or mitigating hazardous contamination levels in certainareas.

FIG. 9 depicts a flow chart of an example process 900 for test datageneration, analysis, and reporting that can be implemented in someembodiments of the system 800 of FIG. 8.

The dose preparation system 820, whether volumetric, gravimetric,photographic, or bar code scanning, can be capable of keeping a recordof every dose that was prepared in a particular pharmacy hood or otherwork area or clinical care area, when the dose was prepared and/oradministered, and who prepared and/or administered the dose (forexample, the identity of the pharmacy technician). As described above,this information can be correlated with the results of the contaminationtest.

The correlation algorithm can, in some embodiments, match detectedcontamination with specific personnel who might have created orcontributed to the contamination. For example, if three techniciansworked in a hood, and only one worked with compound x, and compound xwas identified in a contamination test, then the technician who workedwith compound x might be targeted for training or follow up testing.

The correlation algorithm can, in some embodiments, providecontamination test guidance by limiting tests to compounds that wereactually used over a period of time, or used since the lastcontamination test. In a scenario where more than one test is requiredto screen for multiple possible contaminants, the cost may increase fora number of reasons. For example, it may take a longer period of time toperform testing due to more samples being needed. The time it takes torun a test may be longer. Sample preparation may be more complex. Eachtest may have an incremental cost, so tailoring tests may lower theoverall cost. Advantageously, the dose preparation system could directthe user, or an automated system, to perform only contamination testsfor drugs that were prepared in a specific location or hood.

The correlation algorithm can, in some embodiments, improve thespecificity of contamination tests by utilizing a priori knowledge ofdrugs that were prepared in the hood. For example, if a contaminationtest shows a positive result, but is not capable of indicating which ofa family of possible contaminants actually has been identified, thedatabase of drugs prepared in the hood could be queried for all of thosepossible drugs, and the test result narrowed to the ones actuallyprepared. In some implementations, further testing can be performed forthose specific drugs.

The correlation algorithm can, in some embodiments, determine systematicissues with devices used in preparing drugs. Drug preparation systemscan have the capability to store information representing the productsand devices used in drug preparation. For example, information onsyringe types (manufacturer, volume etc.), closed system transferdevices, connectors, spikes, filters, needles, vials, and IV bags, toname a few examples, can be stored along with the drug and diluent datain the preparation systems database. Failures can be linked to specificdevices and directly help with risk mitigation.

The correlation algorithm can, in some embodiments, identify drugmanufacturers, dose and containers that systematically fail, resultingin detected contamination. The correlation algorithm can identifyprocedures that commonly cause contamination, such as reconstitutionsteps.

The system 800 can provide some or all of these analytics, alone or incombination, in various embodiments.

The system 800 can be designed to implement workflows that are initiatedbased on a set of conditions. For example, one condition that cantrigger a workflow is the detection of contamination. Examples ofworkflows are described below.

A decontamination workflow can include the following procedures. Thesystem 800 can instruct a user how to contain and decontaminate aspecific area, depending on what area the test was performed in.Instructions can include audio, text, video, and the like. Afterdecontamination, the workflow can continue to instructions on performingrepeat contamination tests to ensure the area was properlydecontaminated. If testing fails again, the decontamination procedurecan be repeated.

The system 800 can be configured to provide instructions through theuser interface 805 and/or dose preparation system 820 (or any othermeans of communication, including printed instructions, other displays,voice output and input, direct messages to designated users, etc.).These instructions can be configured to be specific for certain sourcesof contaminants.

Another example workflow is repeat testing of the area of contamination,prior to decontamination. This may be a useful workflow if thespecificity of a particular test is not high. The objective could be tore-test with the same test, or perform further tests to identify morespecifically, what the source and/or level of contamination is. Afollow-on step could be specific decontamination instructions, alreadydescribed above.

In various workflows, system 800 can be configured to receive, prompt,and/or wait for input during the workflow to acknowledge completion ofeach step. The system 800 can be configured to capture decontaminationprocedure evidence, such as photographic, video, audio, proximityinformation for future review, training, documentation, and the like.

System 800 can be configured to identify risks from preparation issues.For example, the system 800 can analyze data already captured by a drugpreparation system, or provide means to capture data regarding drugpreparation issues, problems or errors. For example, when material iswasted, the user involved can be questioned about whether there was aspill or any surface contamination that caused the wasting. System 800can link wasting with positive contamination tests, if wasting iscommonly caused by spills.

System 800 can be adapted for use in non-pharmacy healthcareenvironments including, but not limited to, hospitals, clinics, hospiceenvironments, and veterinary treatment centers. The system 800 can beadapted to other areas of patient care, such as the patient floor,nursing, drug delivery (e.g., infusion, injection), patient room,bathroom, etc. Contamination tests can be performed in any of thesesettings, and this data can be fed back to the system 800. As describedabove, detected contamination can be correlated with personnel,protocols followed, specific drugs, devices, locations, and any otherparameter of interest. Any parameter around the delivery of drugs thatcan be encoded can be correlated with the presence of contamination toprovide feedback to risk managers, clinical and pharmacy personnel.Further, dose preparation and dispensing can occur in many locationsoutside the pharmacy, and similar workflows can be employed in thoseareas, including remote contamination test preparation and execution.

The physical location of specific functions performed by the system 800are not restricted to the pharmacy or hospital data center. Anystructure or function of the system 800, including the database,correlation and analysis, data entry, data display, reporting, etc., canbe carried out in any system in any location. A system model may be tohave a central web-based service, for example. Another model may be tohave remote reporting and notification capability through remote deviceslike smart phones, pagers, computers, displays, applications etc.

Supply of devices can be automated through any of the previouslydescribed systems. For example, pharmacies may be provided resupply oftest kits by system 800, and such resupply can be automated in someembodiments by managing an inventory of kits and initiating a resupplywhen stock falls below a certain level.

Implementing Systems and Terminology

Implementations disclosed herein provide systems, methods and apparatusfor detection of the presence and/or quantity of antineoplastic agentsor other environmental contaminants. One skilled in the art willrecognize that these embodiments may be implemented in hardware or acombination of hardware and software and/or firmware.

The assay reader device may include one or more image sensors, one ormore image signal processors, and a memory including instructions ormodules for carrying out the processes discussed above. The device mayalso have data, a processor loading instructions and/or data frommemory, one or more communication interfaces, one or more input devices,one or more output devices such as a display device and a powersource/interface. The device may additionally include a transmitter anda receiver. The transmitter and receiver may be jointly referred to as atransceiver. The transceiver may be coupled to one or more antennas fortransmitting and/or receiving wireless signals.

The functions described herein may be stored as one or more instructionson a processor-readable or computer-readable medium. The term“computer-readable medium” refers to any available medium that can beaccessed by a computer or processor. By way of example, and notlimitation, such a medium may comprise RAM, ROM, EEPROM, flash memory,CD-ROM or other optical disk storage, magnetic disk storage or othermagnetic storage devices, or any other medium that can be used to storedesired program code in the form of instructions or data structures andthat can be accessed by a computer. It should be noted that acomputer-readable medium may be tangible and non-transitory. The term“computer-program product” refers to a computing device or processor incombination with code or instructions (e.g., a “program”) that may beexecuted, processed or computed by the computing device or processor. Asused herein, the term “code” may refer to software, instructions, codeor data that is/are executable by a computing device or processor.

The various illustrative logical blocks and modules described inconnection with the embodiments disclosed herein can be implemented orperformed by a machine, such as a general purpose processor, a digitalsignal processor (DSP), an application specific integrated circuit(ASIC), a field programmable gate array (FPGA) or other programmablelogic device, discrete gate or transistor logic, discrete hardwarecomponents, or any combination thereof designed to perform the functionsdescribed herein. A general purpose processor can be a microprocessor,but in the alternative, the processor can be a controller,microcontroller, or state machine, combinations of the same, or thelike. A processor can also be implemented as a combination of computingdevices, e.g., a combination of a DSP and a microprocessor, a pluralityof microprocessors, one or more microprocessors in conjunction with aDSP core, or any other such configuration. Although described hereinprimarily with respect to digital technology, a processor may alsoinclude primarily analog components. For example, any of the signalprocessing algorithms described herein may be implemented in analogcircuitry. A computing environment can include any type of computersystem, including, but not limited to, a computer system based on amicroprocessor, a mainframe computer, a digital signal processor, aportable computing device, a personal organizer, a device controller,and a computational engine within an appliance, to name a few.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isrequired for proper operation of the method that is being described, theorder and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the claims.

It should be noted that the terms “couple,” “coupling,” “coupled” orother variations of the word couple as used herein may indicate eitheran indirect connection or a direct connection. For example, if a firstcomponent is “coupled” to a second component, the first component may beeither indirectly connected to the second component or directlyconnected to the second component. As used herein, the term “plurality”denotes two or more. For example, a plurality of components indicatestwo or more components.

The term “determining” encompasses a wide variety of actions and,therefore, “determining” can include calculating, computing, processing,deriving, investigating, looking up (e.g., looking up in a table, adatabase or another data structure), ascertaining and the like. Also,“determining” can include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” can include resolving, selecting, choosing, establishingand the like. The phrase “based on” does not mean “based only on,”unless expressly specified otherwise. In other words, the phrase “basedon” describes both “based only on” and “based at least on.”

The previous description of the disclosed implementations is provided toenable any person skilled in the art to make or use implementations ofthe present disclosure. Various modifications to these implementationswill be readily apparent to those skilled in the art, and the genericprinciples defined herein may be applied to other implementationswithout departing from the scope of the present disclosure. Thus, thepresent disclosure is not intended to be limited to the implementationsshown herein but is to be accorded the widest scope consistent with theprinciples and novel features disclosed herein.

What is claimed is:
 1. A hazardous contaminant test system comprising: acollection device comprising: an elongate body forming an enclosure, anassay test strip disposed within the enclosure, the assay test stripcomprising a reaction zone configured to produce an optically-detectablechange in appearance in the presence of a hazardous contaminant, anabsorbent swab material coupled to the elongate body, wherein the swabmaterial is moistened with a solution configured to lift the hazardouscontaminant from a test surface, wherein the elongate body forms ahandle having a first end coupled to the absorbent swab material, asecond end spaced apart from the first end, and an elongate lengthextending therebetween, and a fluid-tight enclosure comprising a fluidpathway between the absorbent swab material and the test strip.
 2. Thehazardous contaminant test system of claim 1, further comprising a capconfigured to seal the first end of the elongate body.
 3. The hazardouscontaminant test system of claim 2, wherein the cap comprises: areservoir containing a fluid configured to flush the hazardouscontaminant from the absorbent swab material; and a frangible sealpositioned between the reservoir and the first end of the elongate bodywhen the cap is applied to the elongate body.
 4. The hazardouscontaminant test system of claim 3, wherein the cap includes a swabreceiving member coupled to the frangible seal, wherein the swabreceiving member is configured such that the absorbent swab materialdoes not enter the swab receiving member when the cap is applied to theelongate body in a first orientation and such that the absorbent swabmaterial enters the swab receiving member when the cap is applied to theelongate body in a second orientation, and wherein the absorbent swabmaterial is configured to break the frangible seal when the cap isapplied to the elongate body in the second orientation.
 5. The hazardouscontaminant test system of claim 3, wherein the cap includes a pumpthat, when activated, opens the frangible seal to release the fluid intothe absorbent swab material.
 6. The hazardous contaminant test system ofclaim 1, wherein the absorbent swab material and the assay test stripare formed from a unitary piece of material, and wherein the fluidpathway comprises a region of the unitary piece of material extendingbetween the absorbent swab material and the reaction zone.
 7. Thehazardous contaminant test system of claim 1, wherein the fluid pathwaycomprises a channel fluidically coupling the absorbent swab material anda sample receiving zone of the assay test strip.
 8. The hazardouscontaminant test system of claim 7, wherein the assay test stripcomprises a length of material extending between the sample receivingzone and the reaction zone, and wherein the length of material isconfigured to wick liquid received in the sample receiving zone to thereaction zone.
 9. The hazardous contaminant test system of claim 1,wherein the width of the assay test strip is different than the width ofthe swab material.
 10. The hazardous contaminant test system of claim 1,wherein a portion of the absorbent swab material extends out a distalend of the elongate body.
 11. The hazardous contaminant test system ofclaim 1, wherein a single structure includes a sealed fluid pathwaybetween a first region and a second region of the collection device,where the collection device receives a hazardous contaminant in thefirst region of the device, moves the hazardous contaminant downstreamalong the fluid pathway to the second region, and binds the hazardouscontaminant to the second region of the device.
 12. The hazardouscontaminant test system of claim 1, further comprising: a detectiondevice comprising: an image sensor positioned to receive light reflectedfrom the reaction zone and configured to generate signals representingan intensity of the received light, and control electronics configuredto analyze the signals and determine the presence of the hazardouscontaminant in the reaction zone.
 13. A hazardous contaminant collectiondevice comprising: an elongate body forming an enclosure; an assay teststrip disposed within the enclosure, the assay test strip comprising areaction zone configured to produce an optically-detectable change inappearance in the presence of a hazardous contaminant; an absorbent swabmaterial coupled to the elongate body, wherein the swab material ismoistened with a solution configured to lift the hazardous contaminantfrom a test surface, wherein the elongate body forms a handle having afirst end coupled to the absorbent swab material, a second end spacedapart from the first end, and an elongate length extending therebetween;and a fluid-tight enclosure comprising a fluid pathway between theabsorbent swab material and the test strip.
 14. The hazardouscontaminant collection device of claim 13, further comprising a capconfigured to seal the first end of the elongate body.
 15. The hazardouscontaminant collection device of claim 14, wherein the cap comprises: areservoir containing a fluid configured to flush the hazardouscontaminant from the absorbent swab material; and a frangible sealpositioned between the reservoir and the first end of the elongate bodywhen the cap is applied to the elongate body.
 16. The hazardouscontaminant collection device of claim 15, wherein the cap is configuredto seal the enclosure to create a fluid-tight chamber.
 17. The hazardouscontaminant collection device of claim 15, wherein the cap includes aswab receiving member coupled to the frangible seal, wherein the swabreceiving member is configured such that the absorbent swab materialdoes not enter the swab receiving member when the cap is applied to theelongate body in a first orientation and such that the absorbent swabmaterial does enter the swab receiving member when the cap is applied tothe elongate body in a second orientation, and wherein the absorbentswab material is configured to break the frangible seal when the cap isapplied to the elongate body in the second orientation.
 18. Thehazardous contaminant collection device of claim 15, wherein the capincludes a pump that, when activated, opens the frangible seal torelease the fluid into the absorbent swab material.
 19. The hazardouscontaminant collection device of claim 13, wherein the absorbent swabmaterial and the assay test strip are formed from a unitary piece ofmaterial, and wherein the fluid pathway comprises a region of theunitary piece of material extending between the absorbent swab materialand the reaction zone.
 20. The hazardous contaminant collection deviceof claim 13, wherein the fluid pathway comprises a channel fluidicallycoupling the absorbent swab material and a sample receiving zone of theassay test strip.
 21. The hazardous contaminant collection device ofclaim 20, wherein the assay test strip comprises a length of materialextending between the sample receiving zone and the reaction zone,wherein the length of material is configured to wick received liquidfrom the sample receiving zone to the reaction zone.
 22. A method oftesting a test surface for the presence of a hazardous contaminant, themethod comprising: removing a cap from an elongate body of a collectiondevice to expose an absorbent swab material coupled to an end of theelongate body, the absorbent swab material pre-moistened with a firstvolume of a solution configured to lift the hazardous contaminant fromthe test surface; wiping the test surface with the absorbent swabmaterial to collect the hazardous contaminant from the test surface;reapplying the cap to the elongate body to seal the absorbent swabmaterial to isolate the collected hazardous contaminant within thecollection device; transferring a volume of liquid from the absorbentswab material to an assay test strip via a fluid-tight path within thecollection device, wherein the assay test strip is sealed within thecollection device; inserting the assay test strip into an assay readerdevice; and based on an output of the assay reader device, identifyingthat the hazardous contaminant is present on the test surface.
 23. Themethod of claim 22, wherein the cap includes a reservoir containing asecond volume of a buffer solution, the method further comprisingreleasing the second volume of the buffer solution into the absorbentswab material.
 24. The method of claim 23, wherein the cap is initiallyapplied to the elongate body in a first orientation in which the swabmaterial does not contact a frangible seal of the reservoir, and whereinreleasing the second volume of the buffer solution comprises pushing thecap onto the elongate body in a second orientation in which the swabmaterial pushes against and opens the frangible seal.
 25. The method ofclaim 23, further comprising activating a pump mechanism of the cap torelease the second volume of the buffer solution into the absorbent swabmaterial.